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Abstract:

At least one exemplary embodiment is directed to a sound isolation device
comprising: an expandable element; and an insertion element, where the
expandable element is operatively attached to the insertion element,
where the expandable element includes an expanding medium, where the
pressure of the expanding medium is varied to vary sound isolation across
the expandable element.

Claims:

1. An occlusion effect mitigation device comprising:an insertion element;
andan expandable element operatively attached to the insertion element,
where the expandable element is configured to expand against a portion of
the walls of a channel forming a sealed chamber in the channel, where the
expansion reduces the occlusion effect in the sealed chamber.

2. The device according to claim 1 where the channel is a flexible
channel.

3. The device according to claim 1, where the insertion element is a
catheter.

4. The device according to claim 3, where the catheter has at least one
interior channel

5. The device according to claim 4, where the at least one interior
channel is configured to transmit acoustic energy.

6. The device according to claim 1, where the expandable element is a
balloon, with an expanding medium inside the balloon, where the expanding
medium is at an operating pressure.

7. The device according to claim 6, where the balloon is at least one of
disk shaped, conical, spherical.

8. The device according to claim 7, where the balloon is configured so
that it can have a linear elongation greater than 50% when inflated at an
operating pressure.

9. The device according to claim 8, where the operating pressure is
between 0.15 and 1 bar gauge pressure.

10. The device according to claim 9, where the interior medium is air.

11. A sound isolation device comprising:an expandable element; andan
insertion element, where the expandable element is operatively attached
to the insertion element, where the expandable element includes an
expanding medium, where the pressure of the expanding medium is varied to
vary sound isolation across the expandable element.

12. The device according to claim 11 where the channel is a flexible
channel.

13. The device according to claim 11, where the insertion element is a
catheter.

14. The device according to claim 13, where the catheter has at least one
interior channel

15. The device according to claim 14, where the at least one interior
channel is configured to transmit acoustic energy.

16. The device according to claim 11, where the expandable element is a
balloon, with an expanding medium inside the balloon, where the expanding
medium is at an operating pressure.

17. The device according to claim 16, where the balloon is at least one of
disk shaped, conical, spherical.

18. The device according to claim 17, where the balloon is configured so
that it can have a linear elongation greater than 50% when inflated at an
operating pressure.

19. The device according to claim 18, where the operating pressure is
between 0.15 and 1 bar gauge pressure.

20. The device according to claim 19, where the interior medium is air.

21. A method of sound isolation comprising:expanding an element to a first
pressure where the expanded element varies the sound isolation across the
element as the pressure exerted by the expanding element is varied.

22. A method of occlusion effect reduction comprising:inserting an
insertion element into a flexible channel; andexpanding an expanding
element, where upon insertion of the insertion element and expansion of
the expanding element a sealed chamber is formed, where when the
expanding element presses against a portion of a wall of the flexible
channel, the occlusion effect in the sealed chamber is reduced.

Description:

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001]This application claims the benefit of U.S. provisional patent
application No. 61/076,122 filed on 26 Jun. 2008. The disclosure of which
is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002]The present invention relates to devices that can be inserted into
orifices and sealed, and more particularly although not exclusively
related to earpieces with expandable systems.

BACKGROUND OF THE INVENTION

[0003]The Occlusion Effect is generally described as the sensation of
increased loudness (sound pressure level), especially in the low
frequencies, that a person experiences to self-generated sounds
(vocalization, chewing, swallowing, walking, and the like), when the ears
are covered (occluded). Note that this resonance amplification can occur
in tubes that have a sealed volume and have acoustic leakage into the
volume. The Occlusion Effect has been identified as a major obstacle to
successful hearing aid use and shallow (within the first 1/2 of the
channel) inserted earpieces. The theories of why the Occlusion Effect
forms and what it is are numerous and diverse and to date no single
explanation has been totally accepted.

[0004]FIG. 3 illustrates typical occlusion effect levels as a function of
frequency for various in-ear devices.

[0005]There are several theories of occlusion effect, they include Outflow
theory (Mach, 1863): Occlusion of ear canal results in an increase in
middle ear impedance, and hence to a decrease in energy lost from inner
ear via ossiculaer chain. Resonance theory (Huizing, 1923): Increased
perception of sound is brought about by the walls of this artificially
closed cavity acting as resonators. Masking theory (Pohlman, 1930;
Hallpike, 1930): Occlusion of ear canal eliminates masking influence of
ambient noise. Inertial/osseotympanic theory (von Bekesy, 1932):
Occlusion effect results from sound pressure increase in auditory canal
with occlusion. Inertia of mandible to skull sets up pressure variations
in EAM. Impedance theory (Huizing, 1960): Occlusion alters the impedance
of the column of air in the canal (increasing it), resulting in improved
coupling of the air in the canal to the middle ear.

[0006]FIG. 4 illustrates several occlusion effect studies and their values
at various frequencies for earphones, while FIG. 5 illustrates several
occlusion effect studies for earmolds. Roughly the occlusion effect is in
the range of 13-25 dB between 250-500 Hz. Roughly from Killion, Wilber,
and Gudmundsen (1988) a shallow insertion has an occlusion effect of
about 13 to 21 dB, while a deep insertion has an occlusion effect of
about 20 dB for a tapered tip, and about -9 to 4 dB for a bony contact
ear inserted device. Related art solutions involve acoustic vents between
the sealed region (now unsealed) and the outside environment of about 3
mm in diameters, however venting has limitations as well, for example
ringing. Another solution is deep insertion with contact in the Bony
section of the ear canal.

[0008]At least one exemplary embodiment is directed to an occlusion effect
mitigation device comprising: an insertion element; and an expandable
element operatively attached to the insertion element, where the
expandable element is configured to expand against a portion of the walls
of a flexible channel forming a sealed chamber in the channel, where the
expansion reduces the occlusion effect in the sealed chamber.

[0009]At least one exemplary embodiment is directed to a sound isolation
device comprising: an expandable element; and an insertion element, where
the expandable element is operatively attached to the insertion element,
where the expandable element includes an expanding medium, where the
pressure of the expanding medium is varied to vary sound isolation across
the expandable element.

[0010]At least one exemplary embodiment is directed to a method of sound
isolation comprising: expanding an element to a first pressure where the
expanded element varies the sound isolation across the element as the
pressure exerted by the expanding element is varied.

[0011]At least one exemplary embodiment is directed to a method of
occlusion effect reduction comprising: inserting an insertion element
into a flexible channel; and expanding an expanding element, where upon
insertion of the insertion element and expansion of the expanding element
a sealed chamber is formed, where when the expanding element presses
against a portion of a wall of the flexible channel, the occlusion effect
in the sealed chamber is reduced.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012]Exemplary embodiments of present invention will become more fully
understood from the detailed description and the accompanying drawings,
wherein:

[0013]FIG. 1 illustrates an ear canal as a non-limiting example of an
orifice that can be sealed forming a resonance chamber;

[0014]FIG. 2 illustrates occlusion effect values of at least one exemplary
embodiment when the device is sealed at various sound isolation values;

[0015]FIGS. 3-5 illustrates various values of the occlusion effect
according to several scientific studies;

[0016]FIG. 6 illustrates sound isolation values (e.g., acoustic energy
absorption and reflection) for an inflatable system according to at least
one exemplary embodiment;

[0017]FIG. 7 illustrates an inflatable device in accordance with at least
one exemplary embodiment;

[0018]FIGS. 8-13, and 15 illustrate at least one method of inflating an
inflatable device in accordance with at least one exemplary embodiment;
and

[0019]FIGS. 14A, 14B, and 14C illustrate various non-limiting examples of
electrode configurations in accordance with at least one exemplary
embodiment.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE PRESENT INVENTION

[0020]The following description of exemplary embodiment(s) is merely
illustrative in nature and is in no way intended to limit the invention,
its application, or uses.

[0021]At least several exemplary embodiments are directed to or can be
operatively used on various wired or wireless earpiece devices (e.g.,
earbuds, headphones, ear terminal, hearing aids, behind the ear devices,
or other acoustic devices as known by one of ordinary skill in the art,
and equivalents).

[0022]Processes, techniques, apparatus, and materials as known by one of
ordinary skill in the art may not be discussed in detail but are intended
to be part of the enabling description where appropriate. For example
material fabrication may not be disclosed, nor attachment procedures
(e.g., adhesive attaching of separate ridge structures), but such, as
known by one of ordinary skill in such arts is intended to be included in
the discussion herein when necessary.

[0023]Notice that similar reference numerals and letters refer to similar
items in the following figures, and thus once an item is defined in one
figure, it may not be discussed or further defined in the following
figures.

[0024]FIG. 1 illustrates a sealed (occluded) ear canal 50, with a sealed
volume 30. Voice can leak 80 into the sealed volume 30 from various
source paths 80A, 80B, and 80C. In one explanation, the leaked acoustic
energy results in an amplification (e.g., by resonance) at certain
frequencies within the sealed volume, resulting in the Occlusion Effect.
If the ear canal (a non-limiting example of an orifice) was unsealed then
no resonance could build and hence there would be no Occlusion Effect.
While the present invention has been described with reference to
exemplary embodiments, it is to be understood that the invention is not
limited to the disclosed exemplary embodiments. The scope of the
following claims is to be accorded the broadest interpretation so as to
encompass all modifications, equivalent structures and functions of the
relevant exemplary embodiments. For example exemplary embodiments do not
require the formation of a sealed chamber in the channel, exemplary
embodiments can increase the sound isolation across the sealed section of
the channel.

[0025]FIG. 1 illustrates at least one exemplary embodiment. An earpiece
100 can include an insertion element 75 operatively connected to a
sealing section. The sealing section can include an expandable element 70
(e.g., expanding polymers, inflatable systems, mechanically expanded
systems, balloons of various shapes, sizes and materials, for example
constant volume balloons (low elasticity<=50% elongation under
pressure or stress) and variable volume (high elastic>50% elongation
under pressure or stress) balloons). Many materials can be used for the
expandable element 70. For example if the interior medium is air then the
material (e.g., membrane) for the expandable element can be chosen so
that the pressurized air (e.g., 0.1 bar gauge to 2 bar gauge) leaks
through the membrane in a chosen period of time (e.g., 5% pressure
decrease in 8 hours). Additionally other fluids (e.g., air, water, oil,
glycerin) can be used as the interior medium. A pumping mechanism can be
used to pressurize the interior medium. For example a manual pump,
electrical pumps, and chemical pumps (e.g., electrolysis).

[0026]FIG. 6 illustrates sound isolation (attenuation+reflection) results
as a function of inflation plotted in semi-log scale. Note that the
inflation can be varied to obtain a variation in the attenuation and/or
acoustic reflection. Additionally the inflation medium (interior medium)
can be either a liquid (e.g., water, baby oil, mineral oil, ), a gas
(e.g., H2O vapor, H2, O2 gas), or a combination of both. Thus in
accordance with at least one exemplary embodiment sound isolation can be
increased as the pressure is increased above a particular seal pressure
value. However if the expandable element is a stressed membrane, then
there can be an elongation % where the acoustic transmission through the
membrane is higher than at larger or lower elongation %. For example if
the stressed membrane is stretched to 50% elongation in one dimension the
acoustic transmission can be lower than unstretched or 150% elongation
stretched (stressed) membranes. The seal pressure value is the pressure
at which the inflatable system (an example of an expandable element) has
conformed to the inside of the orifice (e.g., whether regular or
irregular) such that a drop between the sound pressure level on one side
of the inflatable system is different from the sound pressure level on
the opposite side of the inflatable system by a drop value in a short
period of time. For example when a sudden (e.g., 1 second) drop (e.g., 3
dB) occurs by at a particular seal pressure level (e.g., 2 bar). For
example if a balloon is used where the medium is air, an internal
pressure of 1.2 bar absolute (0.2 bar gauge) can result in a sound
isolation of 20+ dB across the balloon. For permeability consideration,
for example suppose one wishes inflation to last for 8 hours with less
than 5% internal loss of pressure, the permeability will have to be much
better than silicon, for example Teflon. For variable volume balloons
(such as silicon balloon) various high elongation materials (some over
1000%) can have the requisite permeability.

[0027]FIG. 7 illustrates an inflatable system 300 comprising an insertion
element (e.g., 320, multi-lumen tube) and an expandable element (e.g.,
330, urethane balloon, nylon balloon). The expandable element can be
filled with an expanding medium (e.g., gas, liquid, electroactive polymer
or gell) fed via a supply tube (e.g., 340). The device illustrated in
FIG. 7 illustrates a flange 310 (e.g., made of plastic, foam, rubber)
designed to stop at a designated position in the orifice (e.g., at the
opening of the orifice), and an instrument package (e.g., 350) can
include additional devices and equipment to support expansion control
(e.g., power supply and leads, gas and/or fluid generation systems).

[0028]FIG. 8 illustrate at least one exemplary embodiment for pressure
generation and control. The non-limiting example illustrated includes a
balloon (e.g., 430), at least one pressure control vale (e.g., 420A,
420B); electrodes 410, a porous plug (e.g. 440, micro pore plastics that
allow gas to pass but block fluid motion), and optionally a membrane
(e.g., 415, Nafion®) that absorbs the electrolysis medium (e.g., H2O
with NaCl dissolved at 0.001 mole/liter) allowing a current to pass
between the electrodes as if the electrodes were essentially in free
electrolysis material, and at the same time preventing the electrodes
from touching. The membrane facilitates close placement of the electrodes
increasing the electric field and hence the current. As illustrated the
seal pressure value is as discussed above, the operating pressure is some
value greater than the seal pressure value (e.g., 20% greater) at which
an expandable element operates for a given condition. FIG. 8 illustrates
an electrolysis system where the gas generated passes through a porous
plug into a chamber that has control valves. The control values are
designed to allow a certain gauge pressure value to be reached inside the
chamber (e.g., 0.25 bar, 0.5 bar gauge) while allowing gas from the
outside of the chamber to enter if the gauge pressure value drops below a
value (e.g., -0.5 bar gauge), where the gauge pressure in this instance
is calculated as the pressure inside the chamber minus the pressure
outside the chamber. A non-limiting example of sealing time is 12 seconds
for a balloon volume of 1000 mm 3 using <12 volts and less than 300
mamps.

[0030]FIG. 9 is another exemplary embodiment of a pressure generation and
management system in accordance with at least one exemplary embodiment.
In this exemplary embodiment the gas formation is controlled by
controlling the size of the electric field (e.g., by relative placement
of the electrodes (e.g., platinum cylinders)) As the gas is generated
fluid must be displaced and a partially filled balloon can start to fill.
Near the gas formation region a porous plug can be used to let the gas
generated pass and a valve (e.g., duckbill, for example from VERNAY®
or a MINIVALVE®), or other types of valves, such as flapper valves,
umbrella valves, spring and ball valves, and any other valves that have
low leak rates (loss of less than 5% internal pressure in 8-16 hours)),
can be used to control the amount of pressure generated. Note that the
fluid moves 550 by being displaced by controlling where the bubble
formation 560 occurs (e.g., by placing the electrodes closer at the first
desired bubble formation point).

[0031]FIG. 10 illustrates another pressure generation and management
system, which includes a manual depression balder (e.g., 680). When
depressed the gas and/or fluid in the volume defined by the depression
balder (e.g., 680) can be encouraged (e.g., by correctly placed one-way
valves (e.g., 620B, 620C)) to move the evacuated gas and/or fluid along a
tube to further inflate or pressurize an expandable element (e.g., 630
Balloon). Another value (e.g., 620A) can control the largest value of the
pressure.

[0032]FIG. 11 illustrates another non-limiting example of a pressure
generation and management system 700. In the illustrated system an
elastic bladder (e.g., 765) provides a bladder force 775 that can aid in
forcing any formed gas through the porous plug 740.

[0033]FIG. 12 illustrates yet another exemplary embodiment of a pressure
generation and management system 800. In the system illustrated as gas is
formed water is displaced expanding the elastic bladder 865. The
expanding elastic bladder (e.g., compliant urethane) displaces medium
(e.g., 837) in a chamber, where the displaced medium can further inflate
an expanding element (e.g., Balloon 830).

[0034]FIG. 13 illustrates yet another pressure generation and management
system 900 according to at least one exemplary embodiment. As in FIG. 12
the gas is forced through the porous plug (e.g., 940), however in the
configuration illustrated a smaller chamber is constructed with it's own
inflation bladder (e.g., 985) and the pressure control system (e.g.,
valves 920A and 920B) are operatively connected to the smaller chamber.

[0035]Although not mentioned to this point, the electrodes can vary in
shape and relative size. For example the electrode producing more gas
(e.g., the--electrode associated with H formation in water) can be made
large in surface area facilitating more formation area. Additionally the
electrodes can be separated by an electrolysis medium absorber (e.g.,
Nafion®, 1020). FIGS. 14A through 14C illustrate several non-limiting
arrangement of electrodes. Note that electrode material can vary for
example conductive material that will not oxidize in the electrolysis
medium (e.g., stainless steel, platinum, gold). The spacer 1020 that
allows current to flow between electrodes at a level similar to the
current without the spacer but separates the electrodes so there is no
shorting (e.g., Nafion®) This configuration can also keep air in but
not water.

[0036]FIG. 15 illustrates at least one pressure generation and management
system in accordance with at least exemplary embodiment. In this system
the electrodes are surrounded by a water soluble (porous) membrane (e.g.,
Nafion®), so that when gas is produced water is forced through the
membrane while gas is still trapped inside the enclosed membrane chamber.
An opening connected to a porous plug can allow the gas trapped to
escape, and the pressure can be controlled by placing a valve after the
porous plug. Note that the electrodes can position relative to each other
to control the gas formation.

[0037]Note that several configuration illustrate gas as the expanding
and/or displaced medium, note that other exemplary embodiment can use the
same configuration for liquids. For example the displaced medium (e.g.,
937) in FIG. 13 could be a fluid (gas or liquid).

[0038]At least one exemplary embodiment is directed to a device (e.g., an
occlusion effect mitigation device, a sound isolation device, an
earpiece) comprising: an insertion element (e.g., catheter, catheter with
multiple interior channels, tube, body of an earpiece (thus possible
irregular)); and an expandable element (e.g., stressed membrane, balloon,
electroactive membrane, stressed foam or a combination of these)
operatively attached to the insertion element, where the expandable
element is configured to expand against a portion of the walls of a
channel (e.g., an ear canal, nose pipe,) where the device is configured
to seal the channel when expanded (e.g., inflated). Upon sealing the
device can reduce sound transmission and/or the occlusion effect in any
sealed chamber. Note that the catheter can have at least one interior
channel and the interior channel can transmit acoustic energy. In at
least one exemplary embodiment the expandable element is a balloon, with
an expanding medium inside the balloon, where the expanding medium is at
an operating pressure. The balloon can be variable volume (e.g., made of
a material with an linear elongation >50% at operating pressure) or a
constant volume balloon (e.g., a balloon made to a certain shape where
upon inflation at an operating pressure does not expand more than 100% by
volume from its shape volume). Note that the balloon shape can vary and
be irregular or regular, for example disk shaped, conical, and/or
spherical. Note that the operating pressure can be between 0.15 and 1 bar
gauge pressure. Also note that the fluid can be ambient air.

[0039]Thus, the description of the invention is merely exemplary in nature
and, thus, variations that do not depart from the gist of the invention
are intended to be within the scope of the exemplary embodiments of the
present invention. Such variations are not to be regarded as a departure
from the spirit and scope of the present invention.